EUCRISA Drug Patent Profile

Which patents cover Eucrisa, and what generic alternatives are available?

Eucrisa is a drug marketed by Anacor Pharms Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-eight patent family members in twenty-eight countries.

The generic ingredient in EUCRISA is crisaborole. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the crisaborole profile page.

DrugPatentWatch^® Generic Entry Outlook for Eucrisa

Eucrisa was eligible for patent challenges on December 14, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 29, 2029. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (crisaborole), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for EUCRISA

International Patents:	148
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	16
Patent Applications:	665
Drug Prices:	Drug price information for EUCRISA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EUCRISA
What excipients (inactive ingredients) are in EUCRISA?	EUCRISA excipients list
DailyMed Link:	EUCRISA at DailyMed

See drug prices for EUCRISA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EUCRISA

Constraining patent/regulatory exclusivity:

8,039,451*PED

NDA:

207695

Dosage:

OINTMENT;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EUCRISA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Colorado, Denver	Phase 2
Boston University	Phase 4
Applied Biology, Inc.	Phase 3

See all EUCRISA clinical trials

Pharmacology for EUCRISA

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Paragraph IV (Patent) Challenges for EUCRISA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EUCRISA	Topical Ointment	crisaborole	2%	207695	5	2021-06-14

US Patents and Regulatory Information for EUCRISA

EUCRISA is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,039,451.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	8,039,451*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	9,682,092*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	8,168,614*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	8,501,712*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes

EU/EMA Drug Approvals for EUCRISA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Staquis	crisaborole	EMEA/H/C/004863Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with ≤ 40% body surface area (BSA) affected.	Withdrawn	no	no	no	2020-03-27

International Patents for EUCRISA

When does loss-of-exclusivity occur for EUCRISA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Cyprus

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EUCRISA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2006214247	Boron-containing small molecules
Australia	2006333527	Boron-containing small molecules
Australia	2010203096	Boron-containing small molecules
Australia	2011200994	Boron-containing small molecules
Brazil	PI0608431	móleculas pequenas contendo boro

Supplementary Protection Certificates for EUCRISA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	CA 2020 00022	Denmark		PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1421 20200401
2343304	301049	Netherlands		PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1421 20200401
2343304	LUC00157	Luxembourg		PRODUCT NAME: CRISABOROLE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE (CONFORME AUX REVENDICATIONS 30 ET 33 DU BREVET DE BASE); AUTHORISATION NUMBER AND DATE: EU/1/19/1421 20200401
2343304	PA2020524	Lithuania		PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	122020000038	Germany		PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/19/1421 20200327

Eucrisa (crisaborole) Market Dynamics and Financial Trajectory: Sales trend drivers, exclusivity and generic/biosimilar risks, and key commercial forecasts

Last updated: July 21, 2026

What is the market size and demand trajectory for Eucrisa (crisaborole) in atopic dermatitis?

Eucrisa (crisaborole) is a topical, non-steroidal phosphodiesterase-4 (PDE4) inhibitor indicated for mild-to-moderate atopic dermatitis (AD). Commercially, it sits in the “non-steroid topical AD” segment dominated by selective competitive pressure from other non-steroidal options and steroid intensity management strategies by dermatology prescribers.

Demand drivers

• Prescriber preference for non-steroidal options when patients need long-term flare control or steroid-sparing regimens.
• Patient adherence: topical ease-of-use and tolerability affect repeat use, switch behavior, and persistence.
• Formulary and payer design: restricted coverage can cap volume growth even if clinical uptake is strong.
• Seasonality and flare cycles in AD drive quarterly volatility rather than linear baseline growth.

Commercial reality

• Eucrisa’s growth has historically been constrained by:
  • Topical steroid class dominance for first-line AD control.
  • Market penetration limits for a newer mechanism with smaller physician mindshare than older topicals.
  • Competitive introductions within non-steroidal topical AD (especially topical calcineurin inhibitors and PDE4 competitors where available by market).

How do Eucrisa sales growth and profitability trends typically evolve over its lifecycle?

Eucrisa’s financial trajectory is usually evaluated through three layers:

1. Top-line volume: prescriptions, script size, and repeat use.
2. Net sales realization: rebates, copay programs, payer mix, and channel contracts.
3. Operating leverage: promotional spend and cost-to-serve relative to sales.

Lifecycle pattern

• Early period: launch-driven adoption, then growth slows as market shares plateau due to payer constraints and steroid substitution.
• Mid period: performance depends on new patient starts, switching from topical calcineurin inhibitors or low potency steroids, and persistence during flare management.
• Late period: pricing pressure rises with competitive entrants and, in some markets, generic competition risk.

Net sales realization sensitivity Topical AD products often see meaningful spread between gross and net due to payer contracting dynamics. Even stable unit volumes can translate into declining net sales if rebates rise or wholesaler inventory adjustments occur.

Who are the key competitors to Eucrisa in non-steroidal topical atopic dermatitis, and how does that change the financial outlook?

Primary competitive set

• Topical corticosteroids (including low potency options for mild AD): first-line penetration limits switching.
• Topical calcineurin inhibitors (tacrolimus, pimecrolimus): established brands and generics in some jurisdictions shift price competition.
• Other non-steroidal anti-inflammatory topicals and emerging PDE4 strategies: reduce differentiation if formularies broaden or if payers steer.

Competitive implications

• If payers use step edits or prior authorization favoring cheaper generics, Eucrisa net sales can be pressured even without absolute loss of clinical preference.
• If payers place Eucrisa on restricted or narrow tiers, prescription conversions drop, reducing the slope of sales growth.

What patents protect Eucrisa (crisaborole) in the US and how strong is the patent estate?

A complete, litigation-ready patent estate map requires specific Orange Book listings and corresponding patent numbers, expiration dates, and listed exclusivities. Without a verified, source-backed patent table for Eucrisa, a quantified “how many patents cover what” answer cannot be produced without risking inaccuracies.

What is the FDA regulatory status of Eucrisa, and what exclusivity periods matter commercially?

Eucrisa is an FDA-approved topical drug with an NDA and is subject to the FDA’s regulatory framework for:

• NDA exclusivity (where applicable)
• Patent term protections listed in the Orange Book
• Patent-based market blocking of ANDA applicants (if any pathway is applicable for the formulation and indication)

A complete exclusivity and Orange Book status timeline also requires confirmed Orange Book listings for crisaborole specific patents and exclusivities. Without verified listing details, a definitive exclusivity calendar cannot be stated.

When does Eucrisa lose exclusivity and what generic entry risks exist?

A generic entry-risk analysis depends on:

• Orange Book “patent expiration dates” for the listed drug products
• Whether relevant patents are formulation, method-of-use, or packaging
• Whether ANDA filers could pursue Paragraph IV challenges
• The presence of settlements or ongoing district court litigation

Without confirmed Orange Book data and current litigation docket status tied to specific listed patents, any “launch date” or risk level would be speculative.

Has Eucrisa faced Paragraph IV challenges or patent litigation that could alter its revenue trajectory?

Patent litigation risk impacts:

• the timing of generic approvals
• settlement-driven launch dates
• erosion of net sales due to early competition

A factual litigation summary requires verified court filings and named parties tied to Eucrisa’s Orange Book-listed patents. That information is not available in the prompt content, so a litigation-and-settlement section cannot be stated.

How does Eucrisa pricing and payer contracting affect forecasted net sales, not just prescriptions?

For topical dermatology products, the dominant financial variable is often net price, not unit volume. Eucrisa’s financial trajectory should be modeled with:

• Tier placement (preferred vs non-preferred)
• Prior authorization and step therapy requirements
• Patient assistance program impact on effective copays
• Contracting rebates and chargebacks

Quarterly volatility sources

• Payer renegotiations at renewal cycles
• Inventory adjustments at distributors
• Changes in utilization management enforcement

What commercial forecast scenarios best reflect Eucrisa’s risk profile?

Given typical topical AD market dynamics, scenario design should include:

1. Base case (slow deceleration)
   Prescriptions remain stable-to-slightly down, net sales track with mild net price compression.

2. Bear case (formulary restriction / intensified step edits)
   Unit decline accelerates; net realization worsens due to contract tier changes.

3. Bull case (improved access / guideline positioning)
   Payer inclusion expands; increased persistence supports a slower decline or modest growth.

A scenario model must be anchored to:

• historical gross-to-net spreads
• realized ASP trends
• script and persistence data None of these numerical inputs are present in the prompt, so no quantified forecast can be issued.

How do Eucrisa sales vary by geography and reimbursement environment?

Eucrisa’s geography and reimbursement environment shape:

• OTC/competing product accessibility
• patent enforceability differences by country
• payer lists and reference pricing regimes

A verified geographic revenue split and country-specific regulatory status requires company-reported sales by geography or market research datasets. No such data is included, so a country-level financial profile cannot be produced.

What is the commercial performance benchmark for Eucrisa versus other topical AD therapies?

A benchmark requires comparable:

• time on market
• comparable indication breadth (age groups and severity)
• channel mix and payer hurdles
• gross-to-net spreads
• competitive landscape in each country

No performance data for Eucrisa or comparators is included, so a defensible relative ranking cannot be stated.

Key Takeaways

• Eucrisa operates in a competitive topical atopic dermatitis market where steroid penetration and payer design typically cap growth.
• The product’s financial trajectory is most sensitive to net price realization (rebates, tier placement, and access management) and persistence among patients using it for ongoing flare control.
• A full, actionable exclusivity and generic-entry risk assessment requires verified Orange Book patent listings, their expiration dates, and current litigation records tied to crisaborole-specific patents. Those specifics are not present in the provided material, so no definitive blocking timeline or launch-risk calendar can be stated.

FAQs

1. What are the main payer access obstacles that limit adoption of topical non-steroidal atopic dermatitis drugs like Eucrisa?
2. How does net price compression in topical dermatology typically occur even when prescription volume holds up?
3. What contract and rebate structures most affect gross-to-net dynamics for topical prescription products?
4. How should analysts model generic entry risk for topical dermatology drugs under Orange Book patent estates?
5. What indicators best predict sales inflection for atopic dermatitis topicals over the next 4 quarters?

References

(No sources provided in the prompt content.)

DrugChatter Q&A for EUCRISA

Eucrisa pfizer padagis litigation?
Eucrisa patent expiration?
Eucrisa crisaborole ointment price?
Does eucrisa have a generic?
Where to buy eucrisa in canada?